510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,669
176,466 records, page 2742 of 3530
510(k) clearances, page 2742 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K874997Prisma Disposable Straight Irrigating CystotomeAdvanced Surgical Products, Inc.HNYClass I
K874996Prisma Disposable Kuglen Irrigating Lens Manipula.Advanced Surgical Products, Inc.HMXClass I
K874995Prisma Dispos. Curved Lachrymal CannulaAdvanced Surgical Products, Inc.HMXClass I
K874994Prisma Disposable Angled I/a CannulaAdvanced Surgical Products, Inc.HMXClass I
K874993Prisma Disposable Sharp Irrigating CystotomeAdvanced Surgical Products, Inc.HNYClass I
K874992Prisma Disposable Irrigating Lens DialerAdvanced Surgical Products, Inc.HMXClass I
K874991Prisma Disposable Irrigating Iris HookAdvanced Surgical Products, Inc.HNQClass I
K874990Prisma Disposable Silicone BulbAdvanced Surgical Products, Inc.HMXClass I
K874989Prisma Disposable Adapter for IrrigatorsAdvanced Surgical Products, Inc.HMXClass I
K874988Prisma Dispos. Pearce Irrigating Vectus W/one PortAdvanced Surgical Products, Inc.HMXClass I
K874987Prisma Disposable Double I/a CannulaAdvanced Surgical Products, Inc.HMXClass I
K874986Prisma Disposable Retrobulbar NeedleAdvanced Surgical Products, Inc.HMXClass I
K874985Prisma Disposable Capsule PolisherAdvanced Surgical Products, Inc.HMXClass I
K874984Prisma Disposable Micro Irrigating VectusAdvanced Surgical Products, Inc.HMXClass I
K874983Prisma Disposable Angled Irrigating CystotomeAdvanced Surgical Products, Inc.HNYClass I
K874982Prisma Disposable Simcoe ExtractorAdvanced Surgical Products, Inc.HMXClass I
K874981Prisma Disposable J-Shaped I/a CannulaAdvanced Surgical Products, Inc.HMXClass I
K874980Prisma Disposable Lewicky Chamber MaintainerAdvanced Surgical Products, Inc.HMXClass I
K874979Prisma Disposable Mvr/stiletto BladeAdvanced Surgical Products, Inc.HNNClass I
K874978Prisma Disposa. Rycroft Anterior Chamber CannulaAdvanced Surgical Products, Inc.HMXClass I
K874977Prisma Disposable Double I/a Cannula ClosedAdvanced Surgical Products, Inc.HMXClass I
K874976Prisma Dispos. Double Sharp Irrigating CystotomeAdvanced Surgical Products, Inc.HNYClass I
K874975Prisma Disposable Sharp Angled Irrigat. CystotomeAdvanced Surgical Products, Inc.HNYClass I
K874974Prisma Disposable Simcoe Capsule PolisherAdvanced Surgical Products, Inc.HMXClass I
K874973Prisma Disposable Simcoe I/a CannulaAdvanced Surgical Products, Inc.HMXClass I
K874972Prisma Dispos. Bishop-Harmon Irrigating CannulaAdvanced Surgical Products, Inc.HMXClass I
K874971Prisma Disposable Pearce Irrigating VectusAdvanced Surgical Products, Inc.HMXClass I
K874970Prisma Dispos. Troutman Alpha-Chymotrypsin CannulaAdvanced Surgical Products, Inc.HMXClass I
K874969Prisma Disposable Kratz Capsule PolisherAdvanced Surgical Products, Inc.HMXClass I
K874968Prisma Disposable Gills Angled I/a CannulaAdvanced Surgical Products, Inc.HMXClass I
K872889Romeo(tm) Model 1000Diva Medical Systems, Inc.CGAClass II
K870384Endomed 433Henley Intl.LIHClass II
K881296Hearing Aid (All-in-the-Ear)Hearing Aid Co.ESDClass I
K881274Center Bend Arch WiresFlexmedicsEJFClass I
K881248Kodak Automatic Film Feeder, Model 11Eastman Kodak CompanyIXWClass II
K881233Straight Length Arch WiresFlexmedicsEJFClass I
K881209Aso Slide TestNcs Diagnostics, Inc.GTQClass I
K881110Legionella Pneumophilla Histology Control SlidesSigma Diagnostics, Inc.LJGClass I
K881108Pneumocystis Carinii Histology Control SlidesSigma Diagnostics, Inc.LJGClass I
K881043Folding Hospital Cot Nsn 6530-00-299-8517Junkin Safety Appliance Co., Inc.FNJClass I
K880827Accutek Periodontal ProbeSweet Micro Systems, Inc.EIXClass I
K880824Pathfinder(tm) Chlamydia Eia Detection KitKallestad Diag, A Div. of Erbamont, Inc.LJCClass I
K880764G-Cera Porcelain & G-Cera Porcelain ModifierG-C Intl. Corp.ELLClass II
K880483V-Trend Strep a TestTexas Immunology, Inc.GTZClass I
K880430Gram Negative Mic/combo PanelsBaxter Healthcare CorporationJWYClass II
K880417Leptospirosis IhaHillcrest BiologicalsGRYClass II
K880389Meritec(tm)-Campy (Jcl)Meridian Diagnostics, Inc.LQPClass I
K880208Investigation Kit, Sexual Assault DeterminationDresser Argus, Inc.EFQUnclassified
K875113Toxostat M Test KitWhittaker Bioproducts, Inc.LGDClass II
K874791Condoms (Ramses Extra, Sheik Elite and Koromex)Schmid Laboratories, Inc.HISClass II